Regulatory News

Regulatory publications or updates of recommendations, guidelines and reports affecting research in the 3Rs.

International Guidance Document N. 286 on Good In Vitro Method Practices (GIVIMP)

The Organisation for Economic Cooperation and Development (OECD) has published a new Guidance Document (n. 286) on Good In Vitro Method Practices to promote the reliability and integrity of in vitro data used for the safety assessment of chemicals. The document aims at providing technical guidance in order to advance the development of robust and reliable in vitro methods suitable for regulatory purposes. The guidance is targeted primarily at users that implement in vitro methods, but also provides guidance for in vitro method developers. The document contains among others: – Detailed updated information on good practices for in vitro methods; – Description of the key aspects that may impact the reliability and relevance of in vitro data; – Guidance to help ensure that Standard Operating Procedures (SOPs) are well designed, robust, well defined and described. – Description of the importance of reporting criteria, applying good experimental design, establishing acceptance criteria, and performance standards based on scientific evidence from the generated in vitro datasets. More info.

SCHEER – Memorandum on weight of evidence and uncertainties – Revision 2018

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published the Memorandum on weight of evidence and uncertainties. The Memorandum explains how the SCHEER applies the weight of evidence 2 / 5 approach (WoE) and how it deals with analysis and description of uncertainties when conducting risk assessments of stressors to which humans and/or the environment might be exposed. More info.

EFSA – ECHA Guidance on identifying endocrine disruptors

A guidance document for the identification of substances with endocrine disrupting properties in pesticides and biocides has been published. The Guidance document has been developed by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) with the support of the European Commission’s Joint Research Centre. More info.

FSVO updating technical information on animal experimentation

The Federal Food Safety and Veterinary Office has published on the 6 September 2018 a form for proposing updates to technical information on animal experimentation. Technical information on animal experimentation is periodically adapted to the current state of knowledge in order to incorporate improvements for experimental animals rapidly and effectively. Proposals for modification of the technical information may be submitted to the Federal Food Safety and Veterinary Office (FSVO) at any time (oberaufsicht-tv@blv.admin.ch). The form can be downloaded in German, French or English. Editorial changes and updates to the translations are made on an ongoing basis. Updates to contents are adopted annually by the Standing Committee for Animal Welfare, usually at the last meeting of the year. More info can be found on the FSVO website.

FSVO publishes technical information on severity degrees

The Federal Food Safety and Veterinary Office has published on the 30 August 2018 Technical information on animal experimentation regarding severity degrees. The document provides information for the attention of the cantonal authorities responsible for animal experiments, their advisory committees and all persons concerned with animal experiments. It is intended to serve as a guideline for careful assessment of the severity of animal experiments and the genetic constraints on the animals, in order to allow correct classification of animal experiments in severity categories. It is also intended to promote efforts to find less constraining animal models and experimental procedures and thus to support the implementation of the 3R principles in the longer term. More info can be found on the FSVO website.

FSVO publishes technical information on animal welfare-compliant euthanasia of laboratory animals

The Federal Food Safety and Veterinary Office has published on the 22 August 2018 Technical information on animal experimentation regarding the skilled and animal welfare compliant euthanasia of laboratory animals. The document provides information for the attention of the cantonal authorities responsible for animal experiments, their advisory committees and all persons concerned with animal experiments. The gentle, skilled euthanasia of laboratory animals continues the careful handling of each animal used for experiments right through until its death. It represents an effective contribution to animal welfare and helps to minimise the constraint inflicted on the animals. The continuous improvement of euthanasia methods is a key requirement in the implementation of the 3R principles. More info can be found on the FSVO website.